The NATRELLE® Tissue Expanders are used in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expanders are intended for temporary subcutaneous implantation and are not intended for use beyond six months.

Device Description

Allergan's Tissue Expanders are constructed from silicone elastomer and consist of an expansion envelope with a BIOCELL® textured surface, three suture tabs, a MAGNA-SITE® integrated injection site (incorporating a titanium needle guard), and a stable, reinforced base to enable outward expansion. The three suture tabs are attached to the posterior surface of the shell at approximately the 12 o'clock, 4 o'clock, and 8 o'clock positions of the tissue expander. The Tissue Expanders are available in seven styles and each style consists of six sizes for a total of 42 products, to meet diverse surgical needs. The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. All injection sites contain a self-sealing port and a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called NATRELLE® 133 Tissue Expander with Suture Tabs. The submission is for a device modification of an existing predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Technological Characteristics	The modified device utilizes the same fundamental technology as the predicate device, including: - A silicone expansion envelope with a BIOCELL® textured surface. - A silicone injection site with self-sealing port, magnetic locating system, and titanium needle guard.	The modified device uses the same fundamental technological characteristics as the predicate device.
Biocompatibility	Materials used in the suture tabs (Mohawk P118 polyester mesh) must be approved and considered qualified for use in NATRELLE® Tissue Expanders, based on ISO 10993-1:2009 and Allergan's internal standards.	Based on test results, Mohawk P118 polyester mesh is approved and considered qualified for use in the suture tabs. All other materials are identical to the predicate device.
Performance Testing (Suture Tab Bond Integrity)	Suture tab bond integrity must meet pre-determined acceptance criteria as per ISO 14607:2007(E), ASTM F1441, and Allergan's internal standards and procedure.	The device passed all preclinical testing, and pre-determined acceptance criteria were met for suture tab bond integrity.
Safety and Effectiveness	The modification should not introduce new questions of safety and effectiveness.	Preclinical testing indicates no new questions of safety and effectiveness are introduced.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state a "test set" in the context of human data or clinical trials. The studies mentioned are preclinical testing (biocompatibility and performance testing of the device itself).

Sample Size for Test Set: Not applicable in the context of human subjects. For the preclinical tests, specific sample sizes for the materials or devices tested are not provided, only that "test results" and "preclinical testing" were conducted.
Data Provenance: Not applicable in the context of human subjects. The tests were likely conducted on manufactured device components or materials in a laboratory setting by Allergan's internal standards or external laboratories for ISO/ASTM compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. The studies described are preclinical testing, not human-read clinical evaluations. Ground truth for biocompatibility and mechanical performance is established by standardized testing protocols and material specifications, not expert consensus in the clinical sense.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable for preclinical device testing. Adjudication methods are typically used in clinical studies where multiple human readers interpret data, and their findings need to be reconciled to establish a consensus ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study would involve human readers evaluating clinical cases, which is not described in this submission focused on device modification and preclinical testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study (for an algorithm without human-in-the-loop performance) was not done. This submission is for a physical medical device (tissue expander), not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for the studies mentioned is based on:

Standardized Material Specifications: For biocompatibility (ISO 10993-1:2009 and internal standards).
Standardized Mechanical Testing Protocols: For suture tab bond integrity (ISO 14607:2007(E), ASTM F1441, and internal standards).

8. Sample Size for the Training Set

This information is not provided and is not applicable. There is no mention of a "training set" as this is not a submission for an AI/machine learning device. The "training" here refers to the development and validation of the physical product and its manufacturing processes, not an algorithm.

9. How the Ground Truth for the Training Set was Established

This information is not provided and is not applicable. As stated above, this is not an AI/ML device, so the concept of a training set ground truth, in that context, does not apply.

Summary

{0}------------------------------------------------

K102806
page 1/2

510(k) SUMMARY

JAN

			JAN 5 2011
510(k) Owner:	Allergan Medical
Contact:	Micah Schloss
Phone:	805-961-5828
Fax:	714-796-9724
Date Summary Prepared:	September 27, 2010
Device:
Trade Name:	NATRELLE® 133 Tissue Expander with Suture Tabs
Common/Classification Name:	Expander, Skin, Inflatable
Classification Regulation:	LCJ (Unclassified)
Predicate Devices:	NATRELLE® Style 133 Series Tissue Expander Matrix (K862203)
Device Description:	Allergan's Tissue Expanders are constructed from silicone elastomer and consist of an expansion envelope with a BIOCELL® textured surface, three suture tabs, a MAGNA-SITE® integrated injection site (incorporating a titanium needle guard), and a stable, reinforced base to enable outward expansion. The three suture tabs are attached to the posterior surface of the shell at approximately the 12 o'clock, 4 o'clock, and 8 o'clock positions of the tissue expander. The Tissue Expanders are available in seven styles and each style consists of six sizes for a total of 42 products, to meet diverse surgical needs.
	The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. All injection sites contain a self-sealing port and a titanium needle guard to prevent inadvertent puncture through the base of the injection site.
Intended Use:	The NATRELLE® Tissue Expanders are used in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expanders are intended for temporary subcutaneous implantation and are not intended for use beyond six months.

{1}------------------------------------------------

K102806 page 2/2

Allergan Medical

Special 510(k): Device Modification NATRELLE® 133 Tissue Expanders with Suture Tabs

The predicate device and the modified device utilize the same fundamental Technological Characteristics: technology:

· A silicone expansion envelope with a BIOCELL® textured surface, which expands with sequential injections of sterile saline
· A silicone injection site, with self-sealing port, a magnetic locating system and a titanium needle guard

In accordance with ISO 10993-1:2009 and Allergan's internal standards and Biocompatibility procedures, a biocompatibility review of Mohawk P118 polyester mesh was Data: performed. Based on the test results, the material is approved and considered qualified for use in the suture tabs of NATRELLE® Tissue Expanders. All other materials used in NATRELLE® Tissue Expanders are identical to those used in the predicate device.

Suture tab bond integrity was tested in accordance with ISO 14607:2007(E), Performance ASTM F1441 and Allergan's internal standards and procedure, and Testing: predetermined acceptance criteria were met.

The device passed all preclinical testing, indicating that no new questions of Conclusions: safety and effectiveness are introduced with the proposed modification. NATRELLE® 133 Tissue Expander with Suture Tabs is substantially equivalent to Allergan's currently marketed NATRELLE® Style 133 Series Tissue Expander Matrix (K862203).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

3 - 11

the state of the state of the states of the states of

Allergan Medical % Mr. Micah Schloss Associate Regulatory Analyst 71 S. Los Carneros Road Goleta, California 93117-5506

Re: K102806

Trade/Device Name: NATRELLE® Tissue Expanders Regulation Number: 21 CFR 878.3600 Regulation Name: Tissue expander Regulatory Class: II Product Code: LCJ Dated: December 3, 2010 Received: December 8, 2010

Dear Mr. Schloss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

{3}------------------------------------------------

Page 2 - Mr. Micah Schloss

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electionic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1118809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, pease note the regulation entitled, "Misbranding by reference to premarket notification" (21 CIFR Preu 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Arij. Vs. Nh
fr.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Allergan Medical

Special 510(k): Device Modification NATRELLE® 133 Tissue Expanders with Suture Tabs

Indications for Use

510(k) Number (if known):

K102806

Device Name:

NATRELLE® Tissue Expanders

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Daniel Krone for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number	K102806

Regulation Number and Section

N/A